Trial Outcomes & Findings for Comparison of Intravascular Uptake and Pain Perception During Epidural Injection Using 22 Gauge vs 25 Gauge Needle (NCT NCT04350307)
NCT ID: NCT04350307
Last Updated: 2020-07-20
Results Overview
The intravascular uptake percentage reported in the study is the percent of 'needles' that showed intravascular uptake. Hence higher 'intravascular uptake percentage' means worse outcome. The mean percentages were averaged across participants were compared between treatment arms. Presence or absence of intravascular uptake during live fluoroscopy and/or blood aspiration per needle. Once needle reached its target (epidural space), contrast was injected to confirm the presence or absence of intravascular uptake via live fluoroscopy or aspiration was attempted using a syringe to confirm the presence or absence of intravascular uptake. If contrast pattern suggested needle was in a vessel or blood was aspirated using a syringe, outcome measure was marked 'PRESENT'. If contrast pattern suggested needle was not in a vessel and no blood was aspirated using a syringe, outcome measure was marked 'ABSENT'. In other words, primary outcome measure was binary in nature.
COMPLETED
NA
162 participants
During the procedure
2020-07-20
Participant Flow
Participant milestones
| Measure |
22-Gauge Arm
Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle
22-gauge needle: 22-gauge Quincke needle used for epidural injection
|
25-Gauge Arm
Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle
25-gauge needle: 25-gauge Quincke needle used for epidural injection
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
78
|
|
Overall Study
COMPLETED
|
84
|
78
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
22-Gauge Arm
n=84 Participants
Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle
22-gauge needle: 22-gauge Quincke needle used for epidural injection
|
25-Gauge Arm
n=78 Participants
Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle
25-gauge needle: 25-gauge Quincke needle used for epidural injection
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=84 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=162 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=84 Participants
|
20 Participants
n=78 Participants
|
44 Participants
n=162 Participants
|
|
Age, Categorical
>=65 years
|
60 Participants
n=84 Participants
|
58 Participants
n=78 Participants
|
118 Participants
n=162 Participants
|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 2 • n=84 Participants
|
57 years
STANDARD_DEVIATION 3 • n=78 Participants
|
58 years
STANDARD_DEVIATION 2 • n=162 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=84 Participants
|
37 Participants
n=78 Participants
|
83 Participants
n=162 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=84 Participants
|
41 Participants
n=78 Participants
|
79 Participants
n=162 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
84 participants
n=84 Participants
|
78 participants
n=78 Participants
|
162 participants
n=162 Participants
|
PRIMARY outcome
Timeframe: During the procedureThe intravascular uptake percentage reported in the study is the percent of 'needles' that showed intravascular uptake. Hence higher 'intravascular uptake percentage' means worse outcome. The mean percentages were averaged across participants were compared between treatment arms. Presence or absence of intravascular uptake during live fluoroscopy and/or blood aspiration per needle. Once needle reached its target (epidural space), contrast was injected to confirm the presence or absence of intravascular uptake via live fluoroscopy or aspiration was attempted using a syringe to confirm the presence or absence of intravascular uptake. If contrast pattern suggested needle was in a vessel or blood was aspirated using a syringe, outcome measure was marked 'PRESENT'. If contrast pattern suggested needle was not in a vessel and no blood was aspirated using a syringe, outcome measure was marked 'ABSENT'. In other words, primary outcome measure was binary in nature.
Outcome measures
| Measure |
22-Gauge Arm
n=84 Participants
Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle
22-gauge needle: 22-gauge Quincke needle used for epidural injection
|
25-Gauge Arm
n=78 Participants
Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle
25-gauge needle: 25-gauge Quincke needle used for epidural injection
|
|---|---|---|
|
Intravascular Uptake
|
5.9 percentage of total number of needle
Interval 1.9 to 9.8
|
7.1 percentage of total number of needle
Interval 2.4 to 11.8
|
SECONDARY outcome
Timeframe: During the procedurePopulation: Average NRS during the initial needle entry
Patient reported pain during the procedure (on initial needle entry) on the numerical rating scale (NRS 1-10). Higher numbers implies higher severity of pain. Lower numbers implies lower severity of pain
Outcome measures
| Measure |
22-Gauge Arm
n=84 Participants
Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle
22-gauge needle: 22-gauge Quincke needle used for epidural injection
|
25-Gauge Arm
n=78 Participants
Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle
25-gauge needle: 25-gauge Quincke needle used for epidural injection
|
|---|---|---|
|
Patient Reported Pain
|
3.46 score on a scale
Interval 2.94 to 3.98
|
3.13 score on a scale
Interval 2.57 to 3.69
|
Adverse Events
22-Gauge Arm
25-Gauge Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place